Certificates & Compliance

ISO 13485:2016

Our quality management system is certified to ISO 13485, the international standard for medical device manufacturing, covering design controls, risk management and production traceability.

ISO 9001:2015

STRIDEMECH maintains ISO 9001 certification across all manufacturing operations, ensuring consistent process control and continuous improvement.

CE Declaration & MDR Compliance

All STRIDEMECH products carry CE declaration and are manufactured in accordance with Medical Device Regulation (EU) 2017/745 requirements, enabling distribution across European and international markets.

Documentation Requests

Distributors and clinical partners may request full certification documentation and test reports through our contact form.